Zutectra is an HBIg preparation for subcutaneous injection that is approved in the EU for the 'prevention of HBV reinfection in HBV DNA negative patients ≥ 6 months after liver transplantation for hepatitis B induced liver failure'. The purpose of this study is to show that earlier subcutaneous HBIg treatment with Zutectra after liver transplantation can prevent hepatitis B reinfection.

Treatment with subcutaneous HBIg (Zutectra) at home is manageable for the majority of patients and is more convenient for patients compared to intravenous treatment that must take place in the hospital setting.

Fourty patients will take part in the study at approximately 19 centres in UK, France, Italy and Spain. Patients who are eligible for the study will receive treatment with Zutectra for 24 weeks.

During the study, the safety and effectiveness of Zutectra will be assessed by checking for symptoms of hepatitis B related infection, as well as monitoring blood levels of antiHBs antibodies and hepatitis B surface antigen (HBsAg).

Written informed consent obtained prior to orthotopic liver transplantation (OLT) - not more than 3 months before OLT

Historical evidence within the last 4 weeks that HBV-DNA is undetectable at time point of signature of Informed Consent

Male and female patients (age 18-75 years)

Patients with the diagnosis of liver failure with hepatitis B infection

Patients undergoing liver transplantation or re-transplantation

HBsAg negative on day 7 or on day 14 after OLT

HBV-DNA undetectable at OLT

Serum HBs antibody concentration on day 7 or on day 14 after OLT ≥ 400 IU/l

Stable patient in a condition which in the opinion of the investigator would permit safe participation in the study

Willingness to fill out patient diary

Exclusion Criteria:

Re-transplantation due to viral recurrence

Positive HIV or HCV test at time of transplantation

HBV-DNA positive at OLT

Patients having received organs from HBsAg positive donors

Pregnancy or unreliable contraceptive measures or lactation period (females only)

Known intolerance to immunoglobulins or comparable substances (e.g. vaccination reaction)

Known intolerance to proteins of human origin

Participation in another interventional clinical trial within 90 days before entering the study or during the study and/or previous participation in this study (except screening failures)

Suspicion of drug and/or alcohol abuse

Inability or lacking motivation to participate in the study

Employee or direct relative of an employee of the CRO, the study site, or Biotest

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01856413

Locations

France

Hopital de la Croix Rousse

Lyon, France, 69004

Hôpital Paul Brousse

Villejuif, France, 94804

Italy

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Bari, Italy, 70124

S. Orsola Hospital

Bologna, Italy, 40138

Azienda ospedaliera "G. Brutzu" di Cagliari

Cagliari, Italy, CA 09135

Azienda Ospedaliera Ospedale Niguarda Ca Granda-Chirurgia

Milano, Italy, 20162

Liver and Multivisceral Transplant Center, University of Modena and Reggio Emilia